Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II)
Public ClinicalTrials.gov record NCT01215721. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men. Radical prostatectomy is one of the treatment options available for organ-confined disease. Over 100,000 radical prostatectomies cases (total removal of the cancerous prostate by surgery) are performed in the United States yearly. Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life (QOL) scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day. Many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction scores. Abatement of these symptoms can take up to one year in men, and in 5-20% of patients symptoms may persist for longer periods. Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence. This 'Detrusor Muscle' instability results in excess contractions of the urinary bladder ('urgency to urinate'), and can result in the feeling of needing to urinate more frequently. Consistent with this hypothesis of detrusor muscle instability, men with postoperative dribbling had more complaints with urgency, frequency and bother scores when queried with validated questionnaires. We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patient's dribbling of urine. By treating the bladder muscle instability, we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate. This pilot study will assess the statistical requirements for the number of subjects needed for a fully 'powered' randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients' quality of urinary life and improve postoperative urinary incontinence after surgery. \*This study has been modified from the original protocol with the clinicaltrials.gov ID: NCT00581061.
Study identification
- NCT ID
- NCT01215721
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2010
- Primary completion
- Apr 30, 2013
- Completion
- Apr 30, 2013
- Last update posted
- Jan 22, 2014
2010 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01215721, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2014 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01215721 live on ClinicalTrials.gov.